Bioequivalence and Bioavailability Forum

Hi Lucas,

❝ Hi guys.

Don’t forget the girlzzz!

❝ Anvisa is now suggesting the use of EMA's ABEL based on the 2014 WHO guideline. […] The use of semi or partial replicated designs is also allowed, since blood volume might be a problem for 4-period studies.

Good to know. Would mean that we could drop the argument regulator="ANVISA" in some functions of PowerTOST. There are two functions which adjust α in order to preserve the consumer risk at 0.05: scABEL.ad() and sampleN.scABEL.ad(). I had to introduce a lot of special conditions for ANVISA since large adjustments were needed for CV_wR close to 40%.

❝ I've always used FDA's suggestion (appendix E of 2001 guidance) without problems.

Yep. The early versions of ANVISA’s guidelines were practically single-handed developed by Salomon Stavchansky. Hence, a lot of US-background. If ANVISA is following the WHO’s document (which in this section is almost 1:1 to the EMA’s GL) could we assume that we should also use the crippled models given in the EMA’s Q&A-document (Method A and B)? These are not the mixed-effects model given by the FDA (termed in the Q&A document Method C).